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podofilox
Overview
What is Condylox?
Podofilox is an antimitotic drug which can be chemically synthesized or purified from the plant families and (e.g. species of and Condylox Gel 0.5% is formulated for topical administration. Each gram of gel contains 5 mg of podofilox in a buffered alcoholic gel containing alcohol, glycerin, lactic acid, hydroxypropyl cellulose, sodium lactate, and butylated hydroxytoluene.
Podofilox has a molecular weight of 414.4 daltons, and is soluble in alcohol and sparingly soluble in water. Its chemical name is [5R,-(5α, 5aβ, 8aα, 9α]-5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl) furo[3',4':6,7]naphtho-[2,3,-d]-1,3-dioxol-6(5aH)-one.
Podofilox has the following structural formula:
What does Condylox look like?
What are the available doses of Condylox?
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What should I talk to my health care provider before I take Condylox?
Sorry No records found
How should I use Condylox?
Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is indicated in the treatment of mucous membrane warts (see ).
The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated.
Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days. This one week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.
Condylox Gel 0.5% should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized.
Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions. Patients should be instructed to wash their hands thoroughly before and after each application.
What interacts with Condylox?
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What are the warnings of Condylox?
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What are the precautions of Condylox?
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What are the side effects of Condylox?
Sorry No records found
What should I look out for while using Condylox?
Condylox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.
Correct diagnosis of the lesions to be treated is essential. See the subsection of the section. Condylox Gel 0.5% is intended for cutaneous use only.
Drug Product is Flammable.
Keep Away From Open Flame.
What might happen if I take too much Condylox?
Topically applied podofilox may be absorbed systemically (see section). Toxicity reported following systemic administration of podofilox in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible. Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure and seizures. Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.
How should I store and handle Condylox?
StorageCondylox Gel 0.5% is supplied as 3.5 g of clear gel in aluminum tubes with an applicator tip. NDC 0023-6118-03. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children.Rx onlyCondylox Gel 0.5% is supplied as 3.5 g of clear gel in aluminum tubes with an applicator tip. NDC 0023-6118-03. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children.Rx onlyCondylox Gel 0.5% is supplied as 3.5 g of clear gel in aluminum tubes with an applicator tip. NDC 0023-6118-03. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children.Rx only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown.
Non-Clinical Toxicology
Condylox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.Correct diagnosis of the lesions to be treated is essential. See the subsection of the section. Condylox Gel 0.5% is intended for cutaneous use only.
Drug Product is Flammable.
Keep Away From Open Flame.
Bleeding has been reported in patients treated with pentoxifylline with or without concomitant NSAIDs, anticoagulants, or platelet aggregation inhibitors.
Increased prothrombin time has been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.
Concomitant administration of pentoxifylline and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Monitor theophylline levels when starting pentoxifylline or changing dose.
Concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline (see ).
Pentoxifylline has been used concurrently with antihypertensive drugs, beta blockers, digitalis, diuretics, and antiarrhythmics, without observed problems. Small decreases in blood pressure have been observed in some patients treated with pentoxifylline plus nifedipine or captopril; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy. If indicated, dosage of the antihypertensive agents should be reduced.
Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.
Concomitant administration with cimetidine is reported to increase the average steady state plasma concentration of pentoxifylline (~25%) and the Metabolite I (~30%).
Data are not available on the safe and effective use of this product for treatment of warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina). The recommended method of application, frequency of application, and duration of usage should not be exceeded (see ).
In clinical trials with Condylox Gel 0.5%, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period. Severe reactions were most frequent within the first 2 weeks of treatment.
Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters.
The most common systemic adverse event reported during the clinical studies was headache (7%).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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